Sutureless heart valve attachment

ABSTRACT

A prosthetic heart valve having an anchoring sleeve that changes shape when the valve is implanted and contacts the surrounding annulus to prevent migration of the valve. The heart valve may be non-expandable and the anchoring sleeve may provide the primary anchoring structure of the valve. Alternatively, the valve may be expandable wherein the anchoring sleeve supplements the inherent anchoring capacity of the valve structure. The anchoring sleeve is at least partly made of a material that increases in size, i.e., swells, due to absorption of body fluids. For instance, the anchoring sleeve may be formed of an inner material that swells upon contact with body fluids enclosed by a cover. The anchoring sleeve desirably changes shape to provide spaced apart annular flanges for securing the valve around a fibrous annulus. An anchoring sleeve for a prosthetic heart valve having an expandable frame surrounds a majority of the frame and may define an external hourglass configuration.

FIELD OF THE INVENTION

The present invention relates generally to medical devices, and moreparticularly to a heart valve having an anchoring sleeve that changesshape when implanted to anchor the valve without the use of sutures.

BACKGROUND OF THE INVENTION

Heart valve disease continues to be a significant cause of morbidity andmortality, resulting from a number of ailments including rheumatic feverand birth defects. Recent statistics show that valvular heart disease isresponsible for nearly 20,000 deaths each year in the United States, andis a contributing factor in approximately 42,000 deaths. Currently, theprimary treatment of aortic valve disease is valve replacement.Worldwide, there are approximately 300,000 heart valve replacementsurgeries performed annually.

Two primary types of “conventional” heart valve replacements orprostheses are known. One is a mechanical-type heart valve that uses aball and cage arrangement or a pivoting mechanical closure supported bya base structure to provide unidirectional blood flow, such as shown inU.S. Pat. No. 6,143,025 to Stobie, et al. and U.S. Pat. No. 6,719,790 toBrendzel, et al., the disclosures of which is hereby expresslyincorporated by reference. The other is a tissue-type or “bioprosthetic”valve having flexible leaflets supported by a base structure andprojecting into the flow stream that function much like those of anatural human heart valve and imitate their natural flexing action tocoapt against each other and ensure one-way blood flow. One example of aflexible leaflet valve is disclosed in U.S. Pat. No. 6,585,766 to Huynh,et al., the disclosure of which is hereby expressly incorporated byreference.

Conventional heart valve surgery is an open-heart procedure that ishighly invasive, resulting in significant risks include bleeding,infection, stroke, heart attack, arrhythmia, renal failure, adversereactions to the anesthesia medications, as well as sudden death. Whenthe valve is replaced, surgical implantation of the prosthetic valvetypically requires an open-chest surgery during which the heart isstopped and patient placed on cardiopulmonary bypass (a so-called“heart-lung machine”). In one common surgical procedure, the diseasednative valve leaflets are excised and a prosthetic valve is sutured tothe surrounding tissue at the valve annulus. Because of the traumaassociated with the procedure and the attendant duration ofextracorporeal blood circulation, some patients do not survive thesurgical procedure or die shortly thereafter. It is well known that therisk to the patient increases with the amount of time required onextracorporeal circulation. Fully 2-5% of patients die during heartvalve replacement surgery. The average hospital stay is between 1 to 2weeks, with several more weeks to months required for complete recovery.

In recent years, advancements in “minimally-invasive” surgery andinterventional cardiology have encouraged some investigators to pursuereplacement of heart valves using remotely-implanted expandable valveswithout opening the chest or putting the patient on cardiopulmonarybypass. Various percutaneously- or surgically-delivered expandablevalves are also being tested, primarily that use balloon- orself-expanding stents as anchors. For the purpose of inclusivity, theentire field will be denoted herein as the delivery and implantation ofexpandable valves. These valves typically include a scaffold or framethat expands radially outward into direct anchoring contact with theannulus, sometimes assisted with barbs.

For instance, Percutaneous Valve Technologies (“PVT”) of Fort Lee, N.J.and Edwards Lifesciences of Irvine, Calif., have developed aballoon-expandable stent integrated with a bioprosthetic valve havingflexible leaflets. The stent/valve device, marketed under the nameCribier-Edwards™ Aortic Percutaneous Heart Valve, is deployed across thenative diseased valve to permanently hold the valve open, therebyalleviating a need to excise the native valve. The device is designedfor percutaneous delivery in a cardiac catheterization laboratory underlocal anesthesia using fluoroscopic guidance, thereby avoiding generalanesthesia and open-heart surgery.

The uniformity of contact between the expandable valve and surroundingannulus, with or without leaflets, should be such that no paravalvularleakage occurs, and therefore proper expansion is very important. Often,however, the highly calcified annulus in which the expandable valveimplants is extremely uneven resulting in large gaps therebetween.

There remains a need for a prosthetic heart valve that can be surgicallyimplanted in a more efficient procedure that reduces the time requiredon extracorporeal circulation, and there is also a need for an efficientmeans for implanting expandable prosthetic heart valves.

SUMMARY OF THE INVENTION

The present invention provides a non-expandable prosthetic heart valvefor implantation at a heart valve annulus, comprising a non-expandableheart valve frame defining an orifice around an axis, a valve member,and an anchoring sleeve. The valve member includes at least one leafletmounted to the frame and extending within the orifice operable to permitblood flow in one axial direction through the orifice and occlude flowin the opposite direction. The anchoring sleeve surrounds the frame andis at least partly made of a material that increases in size due toabsorption of body fluids. Further, the anchoring sleeve is configuredwith sufficient mechanical strength to provide the primary means foranchoring the prosthetic heart valve to the annulus.

Desirably, the anchoring sleeve comprises an inner swellable materialenclosed within a cover. The cover desirably restrains the innerswellable material from swelling to its maximum possible size. Theswellable material may be selected from the group consisting of anisocyanate prepolymer, a polyol resin/polyether polyol, a hydrophilicacrylic resin base polymer, and a biocompatible hydrogel comprising atleast one polysaccharide. Preferably, the swellable material is capableof swelling between 10-20 times its original size if unconstrained.

The anchoring sleeve may comprise a band that when swelled defines twoaxially spaced-apart flanges each surrounding the frame and a troughtherebetween. For example, the anchoring sleeve comprises an innerswellable material enclosed within a flexible cover having a biasedstructure so as to be flexible in the regions adjacent the flanges butnot therebetween so as to maintain a radial restraint and form thetrough. In one embodiment, the non-expandable heart valve frame definesa nominal radius and the flanges extend radially outward from the troughby at least about 10-12% of the nominal radius. For example, the flangesextend radially outward by at least 3 mm from the trough.

Another aspect of the invention is an expandable prosthetic heart valvefor implantation at a heart valve annulus. The expandable heart valveframe defines an orifice around an axis, and is convertible between afirst, compressed state and a second, expanded state sized to contact aheart valve annulus. A valve member including at least one leafletmounts to the frame and extends within the orifice. The valve member isoperable to permit blood flow in one axial direction through the orificeand occlude flow in the opposite direction when the frame is in itssecond, expanded state. Finally, an anchoring sleeve surrounding amajority of the frame is at least partly made of a material thatincreases in size due to absorption of body fluids, the anchoring sleevebeing configured with sufficient mechanical strength to assist the framein anchoring the prosthetic heart valve to the annulus.

The expandable heart valve frame preferably defines a tubular shape inthe second, expanded state, wherein the anchoring sleeve defines agenerally tubular shape that extends axially nearly the entire length ofthe heart valve frame. Also, the anchoring sleeve when increased in sizedue to absorption of body fluids may define a generally tubular shapewith a pair of axially spaced apart annular flanges. The expandableheart valve frame in the second, expanded state defines a nominal radiusand the flanges desirably extend radially outward from the frame by atleast about 10-12% of the nominal radius, or by at least 3 mm from theframe. The anchoring sleeve when increased in size due to absorption ofbody fluids may alternatively define a pair of axially spaced bulges anda trough therebetween in an hourglass configuration.

A method of anchoring a prosthetic heart valve to a heart valve annulusof the present invention comprises:

-   -   providing a prosthetic heart valve including a heart valve frame        defining an orifice and a one-way valve member mounted to the        frame and extending within the orifice, the prosthetic heart        about further including an anchoring sleeve surrounding the        frame at least partly made of a material that increases in size        due to absorption of body fluids and being configured with        sufficient mechanical strength to assist the frame in anchoring        the prosthetic heart valve to the annulus; and    -   delivering the prosthetic heart valve to a heart valve annulus        and maintaining a desired position of the prosthetic heart valve        long enough for the anchoring sleeve to increase in size from        absorption of body fluids and anchor the prosthetic heart valve        to the annulus.

In the aforementioned method, the annulus may be the aortic between theleft ventricle and the aortic sinus cavities, wherein the valve isdelivered in antegrade fashion from the apex of the left ventricle usingan access catheter having a size of between about 30-50 French.

In one procedure the step of delivering comprises delivering the heartvalve using a catheter over a guide wire, and either balloon expandingthe prosthetic heart valve or permitting it to self-expand such that thesleeve contacts the annulus, and holding the heart valve in place forsufficient time for the anchoring sleeve to increase in size fromabsorption of body fluids and anchor the prosthetic heart valve to theannulus.

In another procedure the anchoring sleeve when increased in size due toabsorption of body fluids defines a pair of axially spaced bulges and atrough therebetween in an hourglass configuration, and wherein themethod includes positioning the trough over the target annulus toprevent migration of the valve. Also, the anchoring sleeve may changeshape immediately upon being exposed to body fluid, and the methodincludes balloon expanding the heart valve to register the trough withthe target annulus and outwardly compress the sleeve between the frameand the target annulus.

A further understanding of the nature and advantages of the presentinvention are set forth in the following description and claims,particularly when considered in conjunction with the accompanyingdrawings in which like parts bear like reference numerals.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and advantages of the present invention will become appreciatedas the same become better understood with reference to thespecification, claims, and appended drawings wherein:

FIG. 1 is a perspective view of a non-expandable prosthetic heart valvehaving an anchoring sleeve of the present invention on an inflow endthereof;

FIG. 2 is a radial cross-sectional view through one side of the inflowend of the prosthetic heart valve of FIG. 1;

FIG. 3 is a perspective view of the prosthetic heart valve of FIG. 1showing the anchoring sleeve in a deployed configuration;

FIG. 4 is a radial cross-sectional view through one side of the inflowend of the prosthetic heart valve of FIG. 3;

FIGS. 5A and 5B are sectional views through one side of an aorticannulus and surrounding anatomical structure showing two stages in thedelivery and implant of the prosthetic heart valve of FIGS. 1-4;

FIG. 6 is a perspective view of an expandable prosthetic heart valvehaving an anchoring sleeve of the present invention thereon;

FIG. 7 is a perspective view of the prosthetic heart valve of FIG. 6showing the anchoring sleeve in a deployed configuration;

FIG. 8 is a perspective view of an expandable prosthetic heart valvehaving an alternative anchoring sleeve of the present invention thereon;and

FIGS. 9A and 9B are sectional views through one side of an aorticannulus and surrounding anatomical structure showing two stages in thedelivery and implant of the prosthetic heart valve of FIG. 8.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention provides a suture-less means for attachingprosthetic heart valves to heart valve annuluses. Sutures are the mostcommon technique for attaching conventional or non-expandable prostheticheart valves, but their usage present some drawbacks, especially anincrease in surgery time as indicated above. The primary means forattaching heart valves disclosed herein involves an anchoring sleevewhich swells upon delivery to the implant location. A preferredembodiment features only the anchoring sleeve which, when expanded,provides a compression or interference fit between a valve support frameand the annulus. However, barbs or other automatically deployinganchoring elements may be used to supplement the function of theanchoring sleeve, and are not excluded by the term suture-less. Theresulting implant procedure using the devices of the present inventionis greatly speeded up from the omission of suturing.

The anchoring sleeve is at least partly made of a material thatincreases in size due to absorption of body fluids (i.e., blood). Theanchoring sleeve is configured to have sufficient mechanical strength toat least assist the frame in anchoring the prosthetic heart valve to theannulus, and in some cases provide the primary anchoring means.Exemplary configurations for the anchoring sleeve will be providedbelow, but the preceding characterization excludes materials that haveno real mechanical strength to anchor the heart valve to the annulus.For example, liquids or gels that are employed on the exterior of heartvalves for various means may be hydrophilic and swell upon exposure tobody fluids. However, these fluids are unable to add more than anincidental amount of anchorage to the existing mechanical anchoringstructure of the heart valve. Therefore, the anchoring sleeve of thepresent invention is distinct from liquids or gels layered on theexterior of a prosthetic heart valve, unless they are designed to hardenor cure to form flanges or ledges that help anchor the valve.

In the present application, a “non-expandable” prosthetic heart valvehas a relatively dimensionally stable frame, but should not beinterpreted to mean completely rigid, as some slight expansion ofconventional “non-expandable” heart valves may be observed from a risein temperature, for example, or other such incidental cause. Conversely,the term “expandable” stent or-frame is used herein to refer to acomponent of a heart valve capable of expanding from a first, deliverydiameter to a second, implantation diameter. An expandable structure,therefore, does not mean one that might merely undergo slight expansion.

As a point of further definition, the term “tissue anchoring member,” orsimply “anchoring member” refers to a structural component of a heartvalve that is capable of attaching to tissue of a heart valve annulus.The anchoring members for expandable valves are most typically tubularstents, or stents having varying diameters. A stent is normally formedof a biocompatible metal wire frame, such as stainless steel, anon-ferromagnetic metal such as ELGILOY (a Co—Cr alloy), or Nitinol.

The term “valve member” refers to that component of a heart valve thatpossesses the fluid occluding surfaces to prevent blood flow in onedirection while permitting it in another. As mentioned above, variousconstructions of valve members are available, including those withflexible leaflets and those with rigid leaflets or a ball and cagearrangement. The leaflets may be bioprosthetic, synthetic, or metallic.

The present application provides an anchoring sleeve that the swellsupon contact with body fluid, or a predetermined time thereafter. Theanchoring sleeve provides a primary means of anchoring conventional,non-expandable heart valves, and can be the primary means of anchoringexpandable valves also. However, a preferred application of theanchoring sleeve for expandable valves is to supplement the existinganti-migration function of the expandable valve frame or stent. That is,the valve frame or stent expands to a particular diameter that is chosento be slightly larger than the tissue orifice at the target annulus.Most prior expandable heart valves rely solely on the interference fitbetween the valve frame and the annulus to anchor the valve in place.Some expandable heart valves also include barbs or other such mechanicalfeatures that tend to pierce the surrounding tissue. Inclusion of theexemplary anchoring sleeve of the present invention around an expandableheart valve frame provides an additional level of interference to moresecurely hold the heart valve in place. Moreover, the anchoring sleevecompresses to a certain degree and thus conforms to the uneven annulusor calcified leaflets, further enhancing the ability to preventmigration of the valve. It is important to understand the distinctionbetween the anchoring function of the anchoring sleeve in conventionalversus expandable heart valves; the former being primary and the latterbeing either primary or supplemental.

FIGS. 1-4 illustrate an exemplary conventional, non-expandable heartvalve 20 having an anchoring sleeve 22 around an inflow end thereof. Theexemplary heart valve 20 is representative of all manners ofnon-expandable valves, but is particularly illustrated as one with threeflexible leaflets 24 supported by three upstanding commissures 26. Thecommissures 26 project in the outflow direction and the valve featuresarcuate cusps 28 generally defining the periphery of each leaflet 24between each two commissures. As shown, the anchoring sleeve 22surrounds the inflow end of the valve 20 just below each of the cusps28. This is the traditional placement of a suture-permeable sewing ring,but should not be considered to limit the relative placement of theanchoring sleeve 22.

An exemplary valve structure is schematically seen in cross-section inFIG. 2 through one of the cusps 28. The exemplary valve 20 includes anundulating wireform 30 having a fabric cover 32 that follows theupstanding commissures 36 and arcuate cusps 28. A cloth-covered stentstructure 34 provides circumferential support at the inflow end of thevalve 20, and is relatively dimensionally stable. Each of the flexibleleaflets 24 is typically secured between the wireform 30 and stentstructure 34. The anchoring sleeve 22 surrounds the stent structure 34at the inflow end of the valve 20. Numerous designs for such flexibleheart valves are suitable for use with the anchoring sleeve 22, and thepreceding structural details of the valve should not be consideredlimiting. Moreover, as mentioned above, the anchoring sleeve 22 can beused on the exterior of mechanical valves too.

In the embodiment of FIGS. 1-4, the anchoring sleeve 22 comprises aninner swellable material 40 enclosed within a cover 42. The anchoringsleeve 22 is shown as generally annular and lying in a plane, althoughother designs might be slightly circumferentially undulating to followthe up-and-down anatomical shape of an aortic annulus. Also, althoughmost conventional prosthetic heart valves have sewing rings that areuniform around their periphery, the anchoring sleeve 22 may berelatively larger (i.e., radially thicker or axially taller) in someareas. For example, the sewing ring disclosed in U.S. Patent PublicationNo. 2007/0016289 filed on Jul. 13, 2005, entitled “Prosthetic MitralHeart Valve Having a Contoured Sewing Ring,” and expressly incorporatedby reference herein, has at least one raised portion on its outflow edgeto better match the contour of the mitral valve annulus. Those of skillin the art will understand that such bulges or other contours may beformed in vivo by a particular design of the shape changing anchoringsleeve 22.

With reference to FIGS. 1-2, the prosthetic heart valve 20 is shown in aconfiguration prior to implant, for example during storage. In thisstate, the anchoring sleeve 22 generally comprises a band with asubstantially rectangular cross-section as seen in FIG. 2. Two axiallyspaced apart ribs 44 extend slightly radially outward. These ribs 44eventually swell farther outward upon implant of the valve 20, as willbe described below. Although they are shown as visible in FIGS. 1-2, theundeployed anchoring sleeve 22 may alternatively have a smooth or linearcross-section sectional outer surface.

FIGS. 3-4 show the heart valve 20 after the anchoring sleeve 22 has beendeployed. As mentioned above, the anchoring sleeve 22 is formed at leastpartly by a swellable material 40 that increases in size. In theillustrated embodiment, the aforementioned ribs 44 enlarge in the radialdirection to form two substantially larger flanges 46 a, 46 b,resembling O-rings. As seen in the view of FIG. 4, the cross-sectionalshape of the anchoring sleeve 22 ultimately resembles the capital letter“B” with an annular groove or trough 48 created between the outflowflange 46 a and the inflow flange 46 b.

There are numerous ways to form the shape-changing or “self-inflating”anchoring sleeve 22 in addition to enclosing a swellable material 40within a cover 42. In this primary configuration, however, the creationof the flanges 46 occurs by locating the swellable material in separateannular bands at the inflow and outflow edges of the anchoring sleeve 22and a non-swellable material therebetween. Alternatively, or in additionto controlling the location of swelling of the swellable material 40,the cover 42 may have a biased design so as to be flexible in theregions adjacent the inflow and outflow edges, but not in the middle soas to maintain a radial restraint and form the trough 48.

Is important to understand that the deployed anchoring sleeve 22 hassufficient mechanical strength to assist in anchoring a prosthetic heartvalve to the annulus. In the illustrated embodiment of FIGS. 1-4, theswellable material 40 in its deployed condition is relatively stiff suchthat the flanges 46 a, 46 b are capable of holding the valve within anannulus without sutures. The flanges 46 in this embodiment comprise theinner material 40 swelled outward and enclosed by the cover 42. Themechanical strength of the flanges 46 therefore is a combination of thephysical properties of the inner material 40 after having swelled andthe cover 42, in conjunction with their size and shape. In a preferredembodiment, the inner material 40 has the ability to swell to 10-20times its original size upon exposure to blood and if unrestrained. Thecover 42 desirably restrains the material 40 so that it swells outwardand completely fills the cover, resulting in relatively firm flanges 46a, 46 b. For example, the material 40 may be permitted by the size ofthe cover 42 to expand to only ½ of its maximum size.

FIGS. 5A-5B schematically illustrate deployment of the valve 20 havingthe anchoring sleeve 22. FIG. 5A shows the valve 20 being deliveredtoward a heart valve annulus 50, in this case the aortic annulus. Itshould be noted that in a conventional surgery to implant anon-expandable heart valve, the native leaflets are typically removedand the annulus 50 sculpted to receive the valve. The annulus 50comprises a relatively fibrous inwardly-directed ledge against which theheart valve 20 may be implanted. As illustrated, the outer diameter ofthe anchoring sleeve 22 is relatively larger than the sculpted annulus50. The surgeon will select the properly sized valve accordingly. In apreferred embodiment, the anchoring sleeve 22 comprises a swellablematerial 40 that expands upon contact with body fluid. Preferably,however, the material 40 does not immediately expand but insteadexhibits a delayed expansion so as to permit delivery and placement atthe annulus without difficulty. This is not unusual because of the timerequired to absorb fluid.

Ultimately, the surgeon positions the valve 20 immediately adjacent theannular ledge 50 and maintains the position long enough for theanchoring sleeve 22 to fully deploy. In this case, the outflow andinflow flanges 46 a, 46 b swell outward to project above and below theannular ledge 50, with the ledge positioned in the trough 48. Again, itshould be mentioned that the annular ledge 50 for the aortic annulus maybe slightly undulating or scalloped as it follows the native commissuresand cusps to which the excised leaflets previously attached. To providea more secure anchoring contact between the valve and annulus,therefore, the anchoring sleeve 22 may be similarly scalloped. In such anon-planar embodiment the surgeon must rotate the prosthetic heart valve20 to align the undulations in the valve with the undulations in theannular ledge 50.

The relative change in radial dimension of the anchoring sleeve 22 mustbe sufficient to hold the heart valve 20 in place once implanted,preventing migration. In a preferred embodiment, the flanges 46 extendradially outward by at least 3 mm from the trough 48. Stated anotherway, the flanges 46 extend radially outward by at least about 10-12% ofthe nominal radius of the valve 20. Prosthetic heart valves areconventionally sized in odd increments of 2 mm starting in 19 mm (i.e.,19, 21, 25, etc.), denoting the outer diameter of the main structuralcomponent of the valve that defines the flow orifice. Therefore, a 21 mmvalve has a nominal radius of 10.5 mm, and the flanges 46 thereforeextend radially outward by at least about 2 mm. Furthermore, in apreferred embodiment the flanges 46 once expanded are spaced apart byabout 4 mm.

Now with reference to FIGS. 6-7, an anchoring sleeve 60 of the presentinvention for use with an expandable prosthetic heart valve 62 is shown.The exemplary heart valve 62 comprises a plurality of struts 64 arrangedaxially and at angles around the circumference to define a tubular framewhen expanded. Flexible leaflets 66 attach to the frame via a fabricinterface 68 and a plurality of sutures 70. Again, the expandable heartvalve 62 shown is exemplary only, and other designs will benefit fromthe addition of the anchoring sleeve 60. These expandable heart valvestypically have an expandable frame as shown with flexible occludingleaflets therewithin. In the prior art, the self- or balloon-expandableframes anchor to the surrounding annulus through a simple interferencefit, barbs, or a particular contour of the frame which provides top andbottom flanges. There are numerous such designs that provide an inherentanchoring capacity, and it should be understood that the anchoringsleeve 60 may be the primary mechanical anchorage or may just assist theframe in preventing migration of the valve.

In this embodiment, the anchoring sleeve 60 defines a generally tubularshape that extends axially nearly the entire length of the heart valve62 and therefore surrounds a majority thereof. A pair of spaced apartannular ribs 72 shown in FIG. 6 shape change into annular flanges 74 asseen in FIG. 7 upon implant in the body. More particularly, theanchoring sleeve 60, or just the portion at the ribs 72, is made atleast partly of the material that swells upon contact with body fluids(i.e., blood). For example, the portion of the anchoring sleeve 60encompassing the ribs 72 may be constructed in a like manner as theanchoring sleeve 22 of FIGS. 1-5.

As seen in FIG. 7, one of the expanded flanges 74 surrounds an inflowend of the prosthetic heart valve 62, while the second flange is axiallyspaced therefrom. The position of the flanges 74 desirably conforms tothe particular target annulus, such that a narrow ledge of the annulusfits within a trough 76 between the flanges. Again, the size, shape, andspacing of the flanges 74 can be modified to conform to differentannuluses (e.g., scalloped), or for the different pathologies (e.g.,greater calcification).

FIG. 8 illustrates an alternative anchoring sleeve 80 for use with anexpandable prosthetic heart valve 82. The heart valve 82 may have thesame construction as the heart valve 62 of FIGS. 6-7, or any otherdesign with an expandable frame and occluding leaflets therewithin. Theanchoring sleeve 80 covers a majority of the exterior of the prostheticheart valve 82, and is shown in its deployed configuration in FIG. 8.The exterior surface of the anchoring sleeve 80 has an inflow bulge 84,an outflow bulge 86, and a depression or trough 88 therebetween. Theradial proportions of the bulges 84, 86 may be similar to thosedescribed above with respect to the flanges 46 of the anchoring sleeve22 of the first embodiment. The contour resembles an hourglass. Thiscontour is designed to receive the target annulus within the trough 88and prevent migration of the valve 82. As before, the anchoring sleeve80 is made at least partly of a material that swells upon implant.

FIGS. 9A and 9B illustrate two steps in a procedure for implanting theprosthetic heart valve 82 having the anchoring sleeve 80 thereon. Inthis sequence, the annulus 90 is the aortic between the left ventricle92 and the aortic sinus cavities 94, and the valve is introduced inantegrade fashion from the apex of the left ventricle. A catheter 100carrying the heart valve 82 advances over a guide wire 102. When inposition adjacent the annulus 90, a balloon 104 carried by the catheter100 inflates, thus outwardly expanding the prosthetic heart valve 82 andanchoring sleeve 80 thereon. Alternatively, the heart valve 82 may be aself-expanding type which is carried within a sleeve and ejectedtherefrom at the annulus 90. Preferably, the valve frame expandssufficiently such that it would contact the annulus even in the absenceof the sleeve 80.

The anchoring sleeve 80 is seen in cross-section in FIG. 9A to have auniform or cylindrical outer profile during delivery. It is not until apredetermined time after implant in the body that the exterior contourseen in FIG. 9B appears from absorption of fluid. It is furtherconceivable that the balloon 104 may be expanded to outwardly compressthe heart valve 82 against the annulus 90 prior to shape change ofanchoring sleeve 80. Soon thereafter or over time, the inflow bulge 84and outflow bulge 86 form to help maintain the proper position of theprosthetic heart valve, and the trough 88 is positioned over the targetannulus to prevent migration of the valve 82. Alternatively, theanchoring sleeve 80 changes shape immediately upon being exposed to bodyfluid, there being no need to maintain a small profile to fit thecompressed valve 82 into the annulus 90.

One particularly useful application for the anchoring sleeves of thepresent invention is in the relatively recent transapical deliverytechnique shown in FIGS. 9A and 9B. In this technique, a relativelylarge access tube or cannula passes through the apex of the leftventricle, and the balloon catheter carrying the prosthetic heart valvepasses therethrough. In contrast to a percutaneous delivery routethrough the vasculature, which limits the access catheter size to about20 French, the size of the access cannula may be up to 50 French,preferably between about 30-50 French. A relatively thick anchoringsleeve 80 may therefore be added to the prosthetic heart valve 82without exceeding surgical constraints.

A number of materials are suitable for use as the the swellable material40. Two such materials are isocyanate prepolymer and polyolresin/polyether polyol. Another potential material is called Hydron(trademark of National Patent Development Corporation, New York, N.Y.),a hydrophilic acrylic resin base polymer disclosed in U.S. Pat. No.3,975,350, expressly incorporated by reference herein. Other swellablematerials suitable for use as the material 40 comprise biocompatiblehydrogels having at least one polysaccharide, as disclosed in U.S.Patent Application No. 2005/0220882, also expressly incorporated byreference herein.

The cover 42 may be a knit polyester fabric about 0.2 mm thick biased soas to be flexible in the regions adjacent the inflow and outflow edges,but not in the middle so as to maintain a radial restraint and form thetrough 48. Alternatively, potential encapsulating/encasing materials forthe cover 42 could be pericardium (various animals) or polymer (e.g.,polyurethane, mylar, carbon nano-tube sheets).

While the invention has been described in its preferred embodiments, itis to be understood that the words which have been used are words ofdescription and not of limitation. Therefore, changes may be made withinthe appended claims without departing from the true scope of theinvention.

1. A non-expandable prosthetic heart valve for implantation at a heartvalve annulus, comprising: a non-expandable heart valve frame definingan orifice around an axis; a valve member including at least one leafletmounted to the frame and extending within the orifice, the valve memberbeing operable to permit blood flow in one axial direction though theorifice and occlude flow in the opposite direction; and an anchoringsleeve surrounding the frame at least partly made of a material thatincreases in size due to absorption of body fluids, the anchoring sleevebeing configured with sufficient mechanical strength to provide theprimary means for anchoring the prosthetic heart valve to the annulus,wherein the anchoring sleeve comprises an inner swellable materialenclosed within a cover.
 2. The heart valve of claim 1, wherein thecover restrains the inner swellable material from swelling to itsmaximum possible size.
 3. The heart valve of claim 1, wherein theswellable material is selected from the group consisting of: anisocyanate prepolymer, a polyol resin/polyether polyol, a hydrophilicacrylic resin base polymer, and a biocompatible hydrogel comprising atleast one polysaccharide.
 4. The heart valve of claim 1, wherein theswellable material is capable of swelling between 10-20 times itsoriginal size if unconstrained.
 5. The heart valve of claim 1, whereinthe anchoring sleeve comprises a band that when swelled defines twoaxially spaced-apart flanges each surrounding the frame and a troughtherebetween.
 6. The heart valve of claim 5, wherein the anchoringsleeve comprises an inner swellable material enclosed within a flexiblecover having a biased structure so as to be flexible in the regionsadjacent the flanges but not therebetween so as to maintain a radialrestraint and form the trough.
 7. The heart valve of claim 5, whereinthe non-expandable heart valve frame defines a nominal radius and theflanges extend radially outward from the trough by at least about 10-12%of the nominal radius.
 8. The heart valve of claim 5, wherein theflanges extend radially outward by at least 3 mm from the trough.
 9. Anexpandable prosthetic heart valve for implantation at a heart valveannulus, comprising: an expandable heart valve frame defining an orificearound an axis, the frame being convertible between a first, compressedstate and a second, expanded state sized to contact a heart valveannulus; a valve member including at least one leaflet mounted to theframe and extending within the orifice, the valve member being operableto permit blood flow in one axial direction through the orifice andocclude flow in the opposite direction when the frame is in its second,expanded state; and an anchoring sleeve surrounding a majority of theframe at least partly made of a material that increases in size due toabsorption of body fluids, the anchoring sleeve being configured withsufficient mechanical strength to assist the frame in anchoring theprosthetic heart valve to the annulus, wherein the anchoring sleeve whenincreased in size due to absorption of body fluids defines a generallytubular shape with a pair of axially spaced apart annular flanges. 10.The heart valve of claim 9, wherein the expandable heart valve framedefines a tubular shape in the second, expanded state, and wherein theanchoring sleeve defines a generally tubular shape that extends axiallynearly the entire length of the heart valve frame.
 11. The heart valveof claim 9, wherein the expandable heart valve frame in the second,expanded state defines a nominal radius and the flanges extend radiallyoutward from the frame by at least about 10-12% of the nominal radius.12. The heart valve of claim 9, wherein the flanges extend radiallyoutward by at least 3 mm from the frame.
 13. The heart valve of claim 9,wherein the anchoring sleeve when increased in size due to absorption ofbody fluids defines a pair of axially spaced bulges and a troughtherebetween in an hourglass configuration.
 14. A method of anchoring aprosthetic heart valve to a heart valve annulus, comprising: providing aprosthetic heart valve including a heart valve frame defining an orificeand a one-way valve member mounted to the frame and extending within theorifice, the prosthetic heart about further including an anchoringsleeve surrounding the frame at least partly made of a material thatincreases in size due to absorption of body fluids and being configuredwith sufficient mechanical strength to assist the frame in anchoring theprosthetic heart valve to the annulus; and delivering the prostheticheart valve to a heart valve annulus and maintaining a desired positionof the prosthetic heart valve long enough for the anchoring sleeve toincrease in size from absorption of body fluids and anchor theprosthetic heart valve to the annulus, wherein the anchoring sleeve whenincreased in size due to absorption of body fluids defines a air ofaxially spaced bulges and a trough therebetween in an hourglassconfiguration, and wherein the method includes positioning the troughover the target annulus to prevent migration of the valve.
 15. Themethod of claim 14, wherein the annulus is the aortic between the leftventricle and the aortic sinus cavities, and the valve is delivered inantegrade fashion from the apex of the left ventricle using an accesscatheter having a size of between about 30-50 French.
 16. The method ofclaim 14, wherein the step of delivering comprises delivering the heartvalve using a catheter over a guide wire, and either balloon expandingthe prosthetic heart valve or permitting it to self-expand such that thesleeve contacts the annulus, and holding the heart valve in place forsufficient time for the anchoring sleeve to increase in size fromabsorption of body fluids and anchor the prosthetic heart valve to theannulus.
 17. The method of claim 14, wherein the anchoring sleevechanges shape immediately upon being exposed to body fluid, and themethod includes balloon expanding the heart valve to register the troughwith the target annulus and outwardly compress the sleeve between theframe and the target annulus.
 18. A non-expandable prosthetic heartvalve for implantation at a heart valve annulus, comprising: anon-expandable heart valve frame defining an orifice around an axis; avalve member including at least one leaflet mounted to the frame andextending within the orifice, the valve member being operable to permitblood flow in one axial direction through the orifice and occlude flowin the opposite direction; and an anchoring sleeve surrounding the frameat least partly made of a material that increases in size due toabsorption of body fluids, the anchoring sleeve being configured withsufficient mechanical strength to provide the primary means foranchoring the prosthetic heart valve to the annulus, wherein theanchoring sleeve comprises a band that when swelled defines two axiallyspaced-apart flanges each surrounding the frame and a troughtherebetween.
 19. The heart valve of claim 18, wherein the anchoringsleeve comprises an inner swellable material enclosed within a flexiblecover having a biased structure so as to be flexible in the regionsadjacent the flanges but not therebetween so as to maintain a radialrestraint and form the trough.
 20. The heart valve of claim 18, whereinthe non-expandable heart valve frame defines a nominal radius and theflanges extend radially outward from the trough by at least about 10-12%of the nominal radius.
 21. The heart valve of claim 18, wherein theflanges extend radially outward by at least 3 mm from the trough.
 22. Amethod of anchoring a prosthetic heart valve to an aortic heart valveannulus, comprising: providing a prosthetic heart valve including aheart valve frame defining an orifice and a one-way valve member mountedto the frame and extending within the orifice, the prosthetic heartabout further including an anchoring sleeve surrounding the frame atleast partly made of a material that increases in size due to absorptionof body fluids and being configured with sufficient mechanical strengthto assist the frame in anchoring the prosthetic heart valve to theannulus; and delivering the prosthetic heart valve to an aortic valveannulus between the left ventricle and the aortic sinus cavities andmaintaining a desired position of the prosthetic heart valve long enoughfor the anchoring sleeve to increase in size from absorption of bodyfluids and anchor the prosthetic heart valve to the annulus, wherein thevalve is delivered in antegrade fashion from the apex of the leftventricle using an access catheter having a size of between about 30-50French.
 23. The method of claim 22, wherein the step of deliveringcomprises delivering the heart valve using a catheter over a guide wire,and either balloon expanding the prosthetic heart valve or permitting itto self-expand such that the sleeve contacts the annulus, and holdingthe heart valve in place for sufficient time for the anchoring sleeve toincrease in size from absorption of body fluids and anchor theprosthetic heart valve to the annulus.
 24. The method of claim 22,wherein the anchoring sleeve when increased in size due to absorption ofbody fluids defines a pair of axially spaced bulges and a troughtherebetween in an hourglass configuration, and wherein the methodincludes positioning the trough over the target annulus to preventmigration of the valve.